The Food Safety and Standards (health Supplements, Nutraceuticals, Foods for Special Dietary Use, Food for Special medical Purpose, Functional Food and Novel Food) Regulations, 2016 allows the use of vitamins/ minerals only up to one RDA in health supplements and nutraceuticals. In view of the growing concern towards unsupervised usage of Health supplements and nutraceuticals and issues regarding ‘Tolerable Upper Limits’ (TUL) of vitamins, minerals the FSSAI had approached the ICMR for guidance on the subject. The ICMR constituted a Committee to examine the matter, which has submitted its report to FSSAI.
Below is a gist of the 94-page Expert Committee of ICMR, which specifies TUL of the micronutrients for the Indian population
Report of Expert Committee of the ICMR
- Allowance of vitamins/ minerals more than RDA in health/ dietary supplements and nutraceuticals
- Safe Upper Limits
Important Notice for Usage
- The Tolerable Upper Limit (TUL) for nutrient intake is NOT to be used for planning diets or fortification standards
- The TUL refers to the intake beyond which adverse effects could occur
- The current TUL is defined only for “unsupervised intake” of nutrients through the entire life or required period of time for the general population
- Special cases, such as supervised intake of antenatal supplements and therapeutic foods, foods for special medical purposes and any other short-term of nutrients prescribed and supervised by medical professionals or qualified dieticians have not been considered in this report.
Tolerable Upper Limit (TUL)
The recommended daily allowance (RDA) for Indians are now proposed to be supplemented with a new value called ‘Tolerance Upper Level’ which is the largest daily intake that is unlikely to cause any harm. It is important to note that the tolerable upper levels indicated for each nutrient are based on chronic exposure and supplements should not be treated casually.
The TUL is the maximum level of habitual intake from all sources of a nutrient or related substance judged to be unlikely to lead to adverse effects in humans. An adverse effect is considered to be a change in morphology, physiology, growth, development, reproduction or lifespan of an organism, system or (sub) population that results in an impairment of functional capacity, an impairment of capacity to compensate for additional stress or an increase in susceptibility to other diseases. The potential risk of adverse effects increases after the intake increases above TUL.
The increased availability and consumption of fortified foods and supplements have sparked concerns about excessive intake of nutrients. It is important to assess the safety of fortification by comparing eventual micronutrient intakes with the TUL. The safety of fortification by comparing eventual micronutrient intake from all sources (natural, fortified and supplements) with TUL. In principle, high levels of micronutrients additions should be avoided even if a micronutrient has no recommended TUL, particularly if there is no evidence of derived benefit from levels of intake in excess of the Recommended Nutrient Intake (RNI).
Examples of adverse effects occurring due to both extremes are as follows
|Nutrient||Intakes below RDA||Intakes if > TUL|
|Iron||Anaemia||GI side effects|
|Zn||Growth Failure||Impairs CU status|
|Vitamin A||Ocular lesions, morbidity and mortality||Liver damage, teratogenicity|
|Vitamin C||Scurvy||GI side effects|
|Vitamin D||Skeletal Deformities||Hypercalcemia|
|Folic Acid||Megaloblastic anaemia||Masking of vitamin B12 deficiency|
The ICMR has created a framework for arriving at Tolerance Upper Limit which includes the following steps
- Hazard identification
- Dose-response assessment
- Derivation of UL
- Specific points to be considered
The ICMR team has also fixed nutrient levels for the fortification of staple foods, processed foods, and dietary supplements. If the nutrients are not part of the food matrix, it shall be per serving or if multiple serving per day, then the total intake per day should not exceed 1RDA. In processed and packaged foods the level of fortification is about 15 to 30 % of RDA. Fortification depends on the quantity of micronutrients recommended for fortification and the daily consumption of the fortified food and so the level has been fixed according to the following criteria.
- RDAs have been determined as being more appropriate for fixing fortification levels, especially in India because food fortification program is still at a nascent stage and it would benefit by having more diversity in fortified products.
- Habitual India diets are mostly cereal-pulse-vegetarian ones with low amounts of non-vegetarian foods and RDA is calculated by taking these facts into consideration.
- While ensuring adequate intake of the nutrient to vulnerable segments, it is also necessary to ensure that those who are already getting adequate intake should not be adversely affected because of excess intake.
- For a majority of the micronutrients, the recommended highest intakes apply to adult males, with the exception of iron, this is because adult males face the lowest risk of micronutrient deficiencies because their overall food intake is high enough to supply the relatively small micronutrient requirements per unit of body weight
- Milk and oil are consumed daily across population groups but the intakes are insufficient so the universal usage of these foods was considered for fortification with vitamin A and D.
- Salt has also been a universal vehicle for iodine for decades and has been considered for fortification with iron also
- Fortified processed foods are formulated with different ingredients and the raw materials have been treated industrially so that they remain preserved. Though processed foods are not consumed by a large population they still have the potential to contribute to daily requirement of nutrients.
Fortification level in iodized salt (double fortified salt)
RDA is also the basis for fixing the levels of iodine (150μg) and iron (10 mg which is 50% of RDA) in double fortified salt and is based on approximate consumption of 10g of salt intake by an adult male.
Fortification level of Vitamin A and D in oil and milk
On account of the fact that more than one vehicle lends itself to fortification with Vitamins A and D like milk and vegetable oil, and also given the tropical climate for vitamin D 1/3 of the daily requirement has been fixed as the fortification level.
Fortification of processed foods
It is assumed that 30% (600 kCal) of an individual’s daily energy intake is derived from fortified processed foods and therefore its contribution would also be limited to a maximum of 1/3 of RDA. All processed packaged foods should carry nutrients labels, indicating total nutrient content and this should be within 15-30% of the RDA.
Levels of vitamins and minerals in food supplements
According to the Food Safety and Standards (health Supplements, Nutraceuticals, Foods for Special Dietary Use, Food for Special medical Purpose, Functional Food and Novel Food Regulations, 2016 the number of nutrients added to the articles of food shall not exceed RDA as specified by the ICMR and in case such standards are not laid out then standards as laid down by the Codex Alimentarius Commission shall apply. In the case of health supplements of vitamins and minerals, the individual nutrient content added shall not be less than 15% RDA, where a nutrient content claim is being made provided that, if the claim of higher nutrient content is made, the nutrient content shall not be less than 30% RDA.
Recommendations of Individual Nutrients
In the absence of widespread use of iron-fortified foods in the country, the expert group considered studies that were conducted within the framework of National Nutrition Anaemia Prophylaxis program. The dosage of iron supplements varied from 20mg for children under 5 who were anemic, and 45mg for 5 to 10 years, 60mg for 10-19 years and women of reproductive age which were advised to be taken with meals to reduce the adverse gastrointestinal effects.
Among children of 2-5 year age group, no adverse gastrointestinal effects have been reported after oral dosage at 20-30 mg daily supplemental iron preparation for 7 -12 months. This suggests that the risk of adverse effects from supplementation including food sources (8.5mg/1000kcal) is considered to be low for this age group. Since these are within the tolerable upper intake level of iron of 40mg suggested by the Institute of Medicine, the same is adopted.
Iron supplementations in the dose range of 60-180mg have been reported to produce adverse, gastrointestinal disturbances among 10-19 year adolescents and pregnant women. The side effects of oral iron preparations increased with an increase in dosage. However, the studies clearly demonstrated benefit from the supplemental iron intake. In the absence of studies with iron doses less than 60 mg/day, it was recommended to consider the upper intake level of 45 mg as suggested by the Institute of Medicine.
In the absence of robust data on dietary zinc intake and copper status and since most of the studies have been carried out with zinc supplements of dosage ranging from 5-40 mg in under 5 years old children with diarrhoea or in malnourished children, tolerance upper limits, as recommended by ICMR is recommended for Indians.
For calcium, the TUL defined by the ICMR (2011) are presented in the table below. The European Food Safety Authority (2012) on the other hand, has not defined TUL for infants, children, and adolescents stating that the data is insufficient.
TUL of calcium intake by ICM 2011
|9-13 years||3,000 mg||3,000 mg|
|14-18 years||3,000 mg||3.000 mg|
|19-30 years||2,500 mg||2,500 mg|
|31-50 years||2,500 mg||2,500 mg|
|51-70 years||2,000 mg||2,000 mg|
|> 70 years||2,000 mg||2,000 mg|
|14-18 years||3000 mg|
|> 18 years||2500 mg|
|14-18 years||3000 mg|
|> 18 years||2500 mg|
For sodium chloride, there is a requirement to bring in awareness by understanding perceptions on salt and exercise so as to change the dietary intake of salt. Since there should not be any conflict with iodine recommendation for lower sodium intake so sodium intake must not be lower than 5g per day which includes invisible salt.
In line with international recommendations, the TUL for iodine in adults is 900μg per day (0.9mg)
Summary for potassium TUL
|CRN UL Supplemental intake||1,500 mg/day (500 mg 3 times a day|
|IOM UL total intake||Not determined|
|EFSA total intake||Not determined|
|EC supplement maximum||Not determined|
|EVM guidance level, supplemental intake||3.700 mg/day|
In line with international recommendations, the TUL for Vitamin A in adults is 3000μg per day
The TUL for Vitamin D is 100μg /day
Vitamin E recommendations
Quantitative summary for Vitamin E TUL
|CRN UL Supplemental intake||1,000 mg 1600 IU/day|
|IOM UL total intake||1,000mg /day|
|EC SCF UL||300 mg/day|
|EC supplement maximum||Not determined|
|EVM SUL, supplemental intake||540 mg (800 IU) day|
Thiamine – No TUL identified
Riboflavin – No TUL identified
Pyridoxine – Adult TUL of 100mg/day
Biotin – No TUL identified
Niacin – TUL for adults of 35 mg / day
Folic Acid – TUL for adults of 1000μg/ day
Vitamin B12 – No TUL identified
TUL for Vitamin C (FNB, IOM, 2000)
|Age / physiological group||UTL
|Age / physiological group||UTL
|1-12 months infant||Not possible||19 years and older adults||2000|
|1-3 years children||400||14-18 y adolescent pregnant women||1800|
|4-8 years children||650||19 y and older adult pregnant women||2000|
|9-13 years children||1200||14-18 y adolescent lactating women||1800|
|14-18 y adolescent||1800||19 y and older adult lactating women||2000|
Recommendation TUL for adults 2000mg/day